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EURneffy positioned to be the first and only needle-free adrenaline option authorized for emergency treatment of allergic reactions (anaphylaxis) in Europe Positive CHMP opinion and recommendation for approval of a mixed application for marketing authorization based on comprehensi...
neffy ® (epinephrine nasal spray) New Drug Application (NDA) and CRL response under review by FDA with anticipated review completion by early October 2024 Response submitted for neffy Marketing Authorization Application (MAA) to EMA’s CHMP; CHMP...
CHMP opinion on neffy Marketing Authorization Application anticipated in the second quarter of 2024 Response addresses all issues previously identified by CHMP, and includes results from a repeat dose PK/PD study of neffy under NAC conditions and updated ...